510(k) K160093 ยท MUJ System, Planning, Radiation Therapy Treatment
RayStation
| Applicant | RaySearch Laboratories AB (PUBL), Stockholm, SE |
| Decision | Substantially Equivalent, Apr 8, 2016 |
| Received | Jan 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160093
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 19, 2025 | RAYSEARCH LABORATORIES AB Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 5.0.2.35 and 5.0.3.17
Software Version: RayStation 5 Service Pack 2 and 3 Open, Classified |
MUJ | None listed |
| Jan 18, 2017 | RAYSEARCH LABORATORIES AB Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatmen Terminated |
MUJ | None listed |
| Nov 9, 2016 | RAYSEARCH LABORATORIES AB RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System
Product Usage:
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The tre Terminated |
MUJ | None listed |
| Oct 11, 2016 | RAYSEARCH LABORATORIES AB Radiation Therapy Treatment Planning System
Product Usage:
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment un Terminated |
MUJ | None listed |
| Sep 1, 2016 | RAYSEARCH LABORATORIES AB RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System
RayStation is a software system designed for treatment planning and analysis of rad Terminated |
MUJ | None listed |
| Jul 1, 2016 | RAYSEARCH LABORATORIES AB RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radi Terminated |
MUJ | None listed |
| May 30, 2016 | RAYSEARCH LABORATORIES AB Radiation Therapy Treatment Planning System, Model 5.0 Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.